Feasibility and Effect Size of an Intervention to Enhance Muscle Strength Assisted by Robotic Technology (ROBERT®) in Subacute Rehabilitation After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Muscle strength in Newton
研究概览
简要总结
Spinal cord injury (SCI) is a devastating life event with long term consequences both physically and mentally. SCI is defined as either complete or incomplete according to the International Standards of the Neurological Classification of SCI. The primary consequence of a SCI is paralysis/partial paralysis affecting the person's ability to independently functioning in everyday life e.g. in and out of bed, sit to stand and walking.
To regain the ability to transfer and walk the most important prerequisite is to rebuild as much strength as possible in the lower extremities. The optimal training paradigm to increase strength in partial paralysed muscles is unclear.
Rehabilitation robots are upcoming methods to treat sensorimotor deficits after SCI.
The rehabilitation robot ROBERT might contribute to enhance muscle strength for people with very weak strength following an incomplete SCI.
The overall objective of this Ph.D project is to investigate the feasibility and effect size of a muscle strength training intervention assisted by ROBERT® for patients with SCI and severe paresis (muscle strength 1-3 in hip flexion).
详细描述
SCI is a devastating life event with long term consequences both physically and mentally.
To regain the ability to transfer oneself and to walk, the most important prerequisite is to rebuild as much strength as possible in the lower extremities. The optimal training paradigm to increase strength in partial paralysed muscles is unclear. The question is whether strength is best improved by applying the principles of progressive resistance training or by focusing on high repetitions with limited resistance.
Rehabilitation robots are upcoming methods to treat sensorimotor deficits after SCI. The rationale is that the use of robotics allows adaptable support and the ability to increase therapy intensity and dose while reducing the physical burden on the therapist.
The rehabilitation robot ROBERT enables the SCI patient to conduct active or guided repetitions of specific movements in the lower extremities in the early rehabilitation phase. The hypothesis is that such use will increase muscle strength faster in the recovery process than when conducting usual physiotherapist training for people with incomplete SCI.
The objective of this PhD project is to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Randomization is performed after baseline assesment. The outcomes assessor will be blinded to treatment/control group at follow-up assesment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SCI (< 12 month),
- •Age ≥ 18 year
- •Muscle strength 1 - 3 in hip flexion in both legs measured by manual muscle testing.
- •Sufficient Danish or English to be able to provide informed consent
排除标准
- •Previous cerebral injury or SCI
- •Previous damage to peripheral nervous system in lower extremities
- •Instable fractures in thorax or lower extremities
- •Muscle strength 0, 4 or 5 in hip flexion
- •Weight > 150 kg
结局指标
主要结局
Change in Muscle strength in Newton
时间窗: At baseline and at 8 weeks
Change in maximal voluntary contraction (MVC) in isometric muscle strength (N) of hip flexion (8 weeks - baseline)
次要结局
- Difference between legs in numbers of hip flexion(At 4 weeks)
- Chance in EMG activity(At baseline and at 8 weeks)
- Change in spasticity(At baseline and at 8 weeks)
- Change in repetitions(At baseline and at 8 weeks)
- Self-rated hip strength(At 8 weeks)
- Change in muscle thickness(At baseline and at 8 weeks)
- Self-rated ability to use leg in function(At 8 weeks)